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/ .... ~ « . *\ * - . V, 



JIB. 2 3 ?002 ) ' * 

THE UNITED STATES PATENT AND TRADEMARK OFFICE 



v fi48lS^plication of : Jean-Luc BALLIGAND et al. 

Serial No.: 10/068.965 Group Art Unit: 1646 

Filed: February 1 1. 2002 Hxaminer: Unassigned 

l or: NOVEL PHARMACEUTICAL COMPOSITIONS FOR MODULATING 
ANGIOGENESIS 

INFORMATION DISCLOSURE STATEMENT UNDER 37 CFR §§ 1.56, 1.97 and 1.98 

. . hereby certify that this oor«apood«« ^M** 

Assistant Commissioner tor Patents deposited with the U.S. rem swwee* ■» ram. v— — 

Washington, D.C. 20231 ?^cZ£g£££^ U . k _ 
gj Name:.. • ;, > -n r f tS^jiV^ . — 



CITED MATERIALS 



Applicant(s) hereby disclose the information listed in the attached form PTO-1449. 

□ Copies of materials listed but not attached were cited in parent application Serial 
No. ; see 37 C.F.R. § 1 .98(d). 

□ Copies of materials listed but not attached were cited in an International Search 

Report dated ; receipt of the International Search Report and copies of 

references was confirmed by the PCT International Division of the U.S. PTO in 
the Notice of Acceptance mailed . 



ADDITIONAL INFORMATION 
L ANGUAGE 

□ All listed materials are in the English language; see 37 C.I .R. § 1 .98. 

D Non-English language references: 

□ The reference(s): in the English-language is (are) indicated by 

commercial data bases to correspond to the referenced ): . respectively. 



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[3 No fee is required for this Information Disclosure Statement because: 

□ This Information Disclosure Statement is being filed within three months 
of the filing date of a national application (other than a CPA) under § 1 .53(d) or 
within 3 months of the date of entry of the national stage under § 1.491 in an 
international application; 

E This Information Disclosure Statement is being filed before the mailing of 
a first action on the merits; 

□ This Information Disclosure Statement is being filed after a first action on 
the merits but before the mailing date of any of a final action under § 1.1 13. a 
notice of allowance under § 1.31 1, or an action that closes prosecution in the 
application, and is accompanied by a certification below. 

□ This Information Disclosure Statement is filed under 37 C.F.R. § 1 .97(i). 

□ A fee is required for this Information Disclosure Statement: 

□ This Information Disclosure Statement is being filed after a first action on 
the merits but before the mailing date of any of a final action under § 1.1 13, a 
notice of allowance under § 1.31 1 or an action that closes prosecution, and is 
accompanied by the fee set forth in §1.1 7(p). 

□ This Information Disclosure Statement is being filed after the mailing date 
of a final rejection or a notice of allowance under § 1 .3 1 1 or an action that closes 
prosecution, but before the payment of the issue fee, and is accompanied by the 
fee set forth in § 1 .1 7(p) and a certification below. 

CERTIFICATION 

□ f ach item of information contained in this Information Disclosure Statement was 
cited in a communication from a foreign patent office in a counterpart foreign 
application not more than three months prior to the filing of this statement. 

□ No item of information contained in this Information Disclosure Statement was 
cited in a communication from a foreign patent office in a counterpart foreign 
application and. to the knowledge of the undersigned, having made reasonable 
inquiry, no such item was known to any individual designated in 37 O R § 
1.56(c). more than three months prior to the filing of this statement. 



DEPOSIT ACCOUNT 



If a fee is due. attached is a check in the amount of $ 



^ I lowever. the Commissioner 



is hereby authorized to charge fees under 37 CFR § 1.16 and §1.17 which may he required to 
facilitate this filing, or credit any overpayment to Deposit Account #13-3402. two copies of this 
paper are attached for this purpose. 



& BRANIGAN. P.C. 
Arlington Courthouse Plaza 1 
2200 Clarendon Blvd. Suite 1400 
Arlington. Virginia 22201 
Telephone: (703) 243-6333 
Facsimile: (703) 243-6410 

Attorney Docket No.: DCLERC-2P1 



MILLER WHITE. ZELANO 




Date: July 18. 2002 
AJZ:jr 




Please type a 




JUL 2 3 2302 w 

sign ( + ) inside this j^&jf 




7 . -jjbr 

ieh&^fofc£fe>lEf^uctK^ Act of 1 995, no persons are 



Substitute for form 1449A/PTO 



INFORMATION DISCLOSURE 
STATEMENT BY APPLICANT 

(use as many sheets as necessary) 



Sheet 



1 



of 



PTO/SB/08A (08-00 ) , 
Approved for use through 10/31/2002 OMB 0651-0031^| 
US Patent and Trademark Office US DEPARTMENT OF COMMERCE 
required to respond to a colecton of information unless ft contains a vabd OMB control nurr 



Complete if Known 



Application Number 



Filing Date 



First Named Inventor 



Group Art Unit 



Examiner Name 



Attorney Docket Number 



10/068,965 



February 11, 2002 



Jean-Luc BALLIGAND et al 



1646 



Unassigned 



DCLERC-2P1 



U.S. PATENT DOCUMENTS 


Examiner 
Initials * 


Cite 
No ' 


U S Patent Document 


Name of Patentee or Applicant 
of Ctted Document 


Date of Publication of 
Cited Document 
MM-DD-YYYY 


Pages Columns Lines. Where Relevant 
Passages or Relevant 
Figures Appear 


Kind Code'' 

Number 

(if known) 

























































































































































































































































FOREIGN PATENT DOCUMENTS 



I Pages, Columns, Lines. 
Where Relevant 
Passages or Relevant 
Figures Appear 



Examiner 
Initials* 



Cite 

No.' 



Foreign Patent Document 



Office' 



Number 4 



Kind Code 
(// known) 



Name of Patentee or 
Applicant of Cited 
Document 



Date of Publication 
of Cited Document 
MM-DD-YYYY 



WIPO 



01/11038. 



A2 



Balligand 



02/15/2001 



WIPO 



00/67737 



WO 



Galper et al. 



11/16/2000 



WIPO 



99/18801 



WO 



Srivastava et al 



04/22/1999 



WIPO 



99/22773 



WO 



Thompson 



05/14/1999 



EP 



0 471 236 



A1 



Takatani 



02/19/1992 





Examiner 
Signature 




Date 

Considered 





EXAMINER Initial if reference considered, whether or not citation is tn conformance with MPEP 609 Draw line through citation if not m conformance 
and not considered Include copy of this form with next communication to applicant 



. r- "•> tie a"\ 

+ ' M ce A ash ngton ? 



»SS SM"! . : — one' ':.^ r 



Please type a plus 




PTO/SB/08A (08-00) 
Approved for use through 10/31/2002 OMB 0651-0031 
US Patent and Trademark Office US DEPARTMENT OF COMMERCE 
Under the Paperwork Reduction Act of 1 995, no persons are required to respond to a colecfton of informabon unless it contains a valid OMB control number 



Substitute for form 1449A/PTO 



INFORMATION DISCLOSURE 
STATEMENT BY APPLICANT 

(use as many sheets as necessary) 



V Sheet I 2 



Complete if Known 



Application Number 



Filing Date 



First Named Inventor 



Group Art Unit 



Examiner Name 



10/068,965 



February 11, 2002 



Jean-Luc BALLIGAND et al. 



1646 



Unassigned 



of 



Attorney Docket Number 



DCLERC-2P1 



OTHER PRIOR ART -- NON PATENT LITERATURE DOCUMENTS 


Examiner 
Initials * 


Cite 
No 1 


Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of 
the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue 
number(s), publisher, city and/or country where published. 


T : 




i 


John R BURNETT et al. , "Inhibition of ACAT by Avasimibe decreases both VLDL and I ni Anoiinnnrntem B 
production in Miniature Pigs", Journal of Lipid Research. Vol., 40, No 7, pp 1 317-1 327. July 1999. 

XP-002156497. 






2 


Jun LIU et al.. "Angiogenesis activators and Inhibitors Differentially regulate Cavelolin-1 expression and Caveolae 
Formation The Journal of Biological Chemistry. Vol 274, No. 22, pp. 15781-15785. May 28, 1999. XP- 

002156496 






3 


O FERON et al., "High LDL-cholesterol Decreases No Production through Enhanced Caveolin Abundance..." 
Annual Meeting of the Professional Research Scientists for Experimental Biology, 99, Washington, DC, 

April 1999, XP-002136666 






4 


D KONG et al., "The Anti-Angiogenic Effects of HMGCOA Reductase Inhibitors: A New Role for RHOA GTPASE 
In the Regulation of Angiogenesis", American Heart Association, vol 1 10. No 18, Dallas TX, November 2. 1999, 

XP000938028. 






5 


Anne LACOUR et al.. "Comparison of Efficacy and Cost Among Ltpid-Lowenng Agents in Patients 
with "Canadian Journal of Cardiology. Vol. 14, pp. 355-361, March 1998. XP-0021 56498 






6 


Takashi OKAMOTO et al.. "Caveolins, a Family of Scaffolding Proteins for Organizing...' . Journal of Biological 
Chemistry, Vol. 273, No. 10, pp 5419-5422, 1998, XP002136663 






7 


Toyoaki MUROHARA et al.. "Nitric Oxide Synthase Modulates Angiogenesis in Response to Tissue Ischemia". 
Journal of Clinical Investigation, Vol. 11, No. 101, pp. 2567-2578. New York. NY, June 1998. XP002138210 






8 


Garcia-Cardena GUILLERMO et al., "Dynamic Activation of Endothelial Nitric Oxide Synthase by Hsp90". Nature 
(London) Vol. 392. No 6678, pp 821-824. April 23. 1998. XP002163482. 






9 


Jeffrey B MICHEL et al , "Reciprocal Regulation of Endothelial NO Synthase by Ca2+ Calmodulin and Caveolin" 
The Journal of Biological Chemistry, Vol 272. No 25, pp 15583-15586. 1997, XP002136665 






10 


Jeffrey B. MICHEL et al "Caveolin versus Calmodulin Conterbalancmg allosteric modulators of endothelial nitric 
oxide snythase". The Journal of Biological Chemistry, Vol 272, No 41. pp 25907-25912, 1997 XP002136661. 




1 i 


James KERWIN et al The Argmme-Nitric Oxide Pathway A Target for New Drugs' Medicinal Research 
Reviews Vol 14. No 1 1994. pp 23-74 XP000906832 




12 


JS HANNAH et al Effects of Acipimox on The Metabolism of Free Fatty Acids and Very Low density Acta 
Diabetolcgica Vol 32 No 4. pp 279-283. 1995. XP-002156499 













Examiner 




Date 




Signature 




Considered 





EXAMINER Initial if reference considered, whether or not citation is in conformance with MPEP 609 Draw line through citation if not in conformance 
and not considered Include copy of this form with next communication to applicant 



Unique citation designation number Applicant is to place a check mark here if English language Translation is attached